2-Amino-2-ethyl-1,3-propanediol

2-アミノ-2-エチル-1,3-プロパンジオール

[CAS No. 115-70-8]

Molecular formula: C5H13NO2 Molecular weight: 119.16

Abstract

A single dose oral toxicity test of 2-amino-2-ethyl-1,3-propanediol was
conducted in female rats at 300 and 2000 mg/kg. No deaths occurred at either
dose level, and the lethal dose was estimated to be higher than 2000 mg/kg.
No abnormalities were observed regarding the general condition or body
weights of any animal or at necropsy.

Oral toxicity was further studied in rats according to the OECD repeated
dose Test Guideline 422 at doses of 0, 250, 500 and 1000 mg/kg. Open field
examination revealed low values for rearing in males of the 1000 mg/kg
group in weeks 3, 4, 5 and 6 of the administration. Histopathological examination
revealed cell infiltration in the mucosa of the forestomach and glandular
stomach, erosion in the glandular stomach, increased numbers of globular
leukocytes in the glandular stomach, thickening of the glandular stomach
mucosa and thickening of the limiting ridge in males of the 1000 mg/kg
group.

The NOELs for repeated dose oral toxicity test were judged to be 500 mg/kg/day
for males and 1000 mg/kg/day for females.

With regard to reproductive/developmental toxicity items, the test substance
showed no adverse effects on any relevant parameters.

The NOELs for the reproductive/developmental toxicity test were judged
to be 1000 mg/kg/day for both male and female parent animals and also for
offspring.

Reverse mutation assays using microorganisms (Salmonella typhimurium TA100,
TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA) were conducted to assess
the potential of 2-amino-2-ethyl-1,3-propanediol to induce gene mutations.
No mutagenic activity was found in the bacteria under the present experimental
conditions.

No deaths occurred at either dose level, and the lethal dose was estimated
to be higher than 2000 mg/kg. No abnormalities were observed in the general
conditions or body weights of any animal or at necropsy.

Open field examination revealed low values for rearing in males of the
1000 mg/kg group in weeks 3, 4, 5 and 6 of the administration, but values
were normal in the test at the end of the recovery period.

Histopathological examination at the end of the administration period revealed
cell infiltration in mucosa of the forestomach and glandular stomach, erosion
in the glandular stomach, increased numbers of globular leukocytes in the
glandular stomach, thickening of the glandular stomach mucosa and thickening
of the limiting ridge in males of the 1000 mg/kg group. At the end of the
recovery period, increased numbers of globular leukocytes in the glandular
stomach and thickening of the limiting ridge were still observed, but their
severity had decreased, suggesting reversibility.

<Reproductive and developmental toxicity>

No test article-related effects were observed in the estrous cycle, number
of days until copulation, copulation index, insemination index, or fertilization
index. Furthermore, there were no effects of test article administration
on the gestation period, birth index, numbers of corpora lutea, numbers
of implantations, implantation index, parturition or nursing behavior,
numbers of stillborn pups, still birth index, numbers of liveborn pups,
liveborn index, sex ratio, observation of liveborn pups at birth or necropsy
at 4 days postpartum, as well as body weights or viability.

<Evaluation>

From the above results, the NOELs for repeat dose toxicity of 2-amino-2-ethyl-1,3-
propanediol were judged to be 500 mg/kg/day for males and 1000 mg/kg/day
for females. The NOELs for reproductive/developmental toxicity were judged
to be 1000 mg/kg/day for both male and female parent animals, and also
for offspring.